Polypodium Leucotomos Extract for the Treatment of Melasma

NCT01092884 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-06

No results posted yet for this study

Summary

We will assess whether oral supplementation with Polypodium leucotomos, a commercially marketed fern extract, improves facial melasma in Hispanic women with moderate to severe melasma. Subjects will be randomized to either Group 1, which will receive oral Polypodium leucotomos extract plus topical sunscreen, or Group 2, which will receive oral placebo plus topical sunscreen. The study will last 12 weeks, and we hypothesize that the Polypodium leucotomos group will have more improvement in their melasma compared to the placebo group.

Conditions

  • Melasma

Interventions

DIETARY_SUPPLEMENT

Polypodium leucotomos extract

240 mg capsule of Polypodium leucotomos extract will be taken orally three times daily

OTHER

Placebo

This placebo capsule will be taken orally three times daily

Sponsors & Collaborators

  • Industrial Farmacéutica Cantabria, S.A.

    collaborator INDUSTRY
  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-07-31
Completion
2012-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01092884 on ClinicalTrials.gov